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<P><FONT face=Arial size=4>Quality 
System <A href="Assessment.htm">Assessment </A>  
 </FONT></P>
<P><FONT size=4 
face=Arial>Supplier:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
Address:</FONT></P>
<P><FONT size=4 
face=Arial>DUNS-Number:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
State/country&amp;Zip-Code:</FONT></P>
<P><FONT size=4 face=Arial>Lead&nbsp;<A href="Auditor.htm">Auditor</A>  
INVACARE:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
Contact person SUPPLIER:</FONT></P>
<P><FONT size=4 
face=Arial>Date(mm/dd/yyyy):&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
<FONT color=#ff0000>Commodity</FONT> 
:</FONT></P>
<P><FONT size=4 face=Arial>One.&nbsp;Quality Systems</FONT></P>
<P><FONT size=4 face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
1(4.1)&nbsp; Does the supplier have a quality management or quality assurance 
system? Is this system <FONT color=#ff0000>mature</FONT>, <FONT 
color=#ff0000>effective</FONT> and known in the whole <FONT 
color=#ff0000>enterprise</FONT>? Does it follow a continuous improvement <FONT 
color=#ff0000>approach</FONT> 
           
             
     ?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2(4.1) 
Or does the supplier have a registered quality management system based on 
ISO9001:2000? Is this system <FONT color=#ff0000>mature</FONT>, <FONT 
color=#ff0000>effectie</FONT>  
           
      and known in the whole enterprise? 
Does it follow a continuous improvement approach?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3(4.1) 
Or does the supplier have a registered or <FONT color=#ff0000>inspected</FONT> 
quality management system based on ISO13485 or the FDA's QSR 21CFR Part 820 or 
ISO/TS16949 or VDA6.3? is this system <FONT color=#ff0000>mature</FONT>  
            
               
 , effective and known inthe whole enterprise? does it follow a 
continuous omprovement approach? Review the results of their last inspections by 
ISO and FDA, if applicable were the generally free of major adverse 
findings?</FONT></P>
<P><FONT size=4 
face=Arial> 
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4(4.1,5.5.3) Are the processes of the quality system known in the whole 
organization and are they documented in an appropriate we? (Working instuctions 
and process instructions, specifications, drawings). Are the methods and 
criteria known to control the processes? (SPC, Skip lot, 100% control, AQL). Are 
subcontracted, separated processes under appropriate control for the risk to the 
finished product? (Processes with sub-suppliers)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5(4.2.3) Does 
documentation exist in the enterprise and are these docucments handled under 
controlled conditions? Checked, approved and releasedbefore use? Date, status, 
check or change index? Availability in the workplace? Readable, understood by 
intended users? No access to invalid/outdated versions?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6(4.2.4) Do 
records exist in the enterprise and are these records controlled as evidence in 
the organization?(easily retrieved, specified retention time, protected 
storage)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 7(5.3) If 
making medical devices, does the operation have a posted Quality Policy? Does 
the policy include a commitment to comply with the requirements and maintain the 
effectiveness of the quality system?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
8(5.2) Are customer specific requirements recognized and implemented by the 
supplier?(Requirement in accordance wih specifications, technical drawings, 
guide for suppliers, packaging specifications, 
etc.)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9(5.1 5.2 
6.1) Does management check customer expectations regularly and provide suitable 
resources to their fulfillment?(Personnel, machines, material)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 10(5.2 5.5.3 
5.6) Does the management review and communicate customer expectations/problems 
in the whole enterprise on a regular basis and take corrective actions based on 
these documented discussions?(Results out of audits, objections out of quality 
reports, statistics out of field, non conformities)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11(5.5.1 
5.5.2) Are responsibility and duties fixed, communicated and 
announced?(Organizational charts, job dscriptions, employment contracts) Is 
there a designated management representative?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12(8.2.1) 
Is customer satisfaction reviewed by the supplier? Is seniro management 
representative(s) involved with customer issue resolution?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13(8.2.1) 
What are the performance levels for quality and delivery(PPM and % on time), as 
indicated from major customers and/or internally tracked performance metrice? 
Are there favorable trends over the last 6 months for these indicators and are 
action plans in place whern issues arise?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14(6.2.1) 
Was the staff selected and evaluated following adequate education, training, 
skills and experiences?</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15(6.2.2) 
In case of deficiencies, new or changed requirements: Does a system exist to 
train or qualify the employees as needed according to the requirements? Is the 
effectiveness of the qualification measures adequate? Is training carried out 
relative to new product or process introduction done with enough time before the 
start of routine production.</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 16(7.3.7 7.5.1 
8.5.1) Do systems exist for the continuous improvement of employees based on 
motivation?(Employees suggestion system, workers activity programs, Quality 
Circles, etc.)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17(6.2.2) 
Where language <A href="barrier.htm">barrier</A> 
  s may exist, are systems in place to ensure the accuracy 
of defined expectations? Do systems exist to avoid such problems in the future? 
(language courses, uniform/international language in drawings, translations in 
national language by process instructions, etc.)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 18(6.3 6.4) 
Does the workplace show adequate cleanliness, order and 
organization?<BR>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Does 
the workplace&nbsp;show&nbsp;adequate lighting, ergonomics and 
security?<BR>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
Does the workplace contain suitable enviroment to ensure product 
conformity?(Hardware and software, suitable packaging and transprot, material 
containers and partial containers, bright storage and dark storage, air 
humidity, electronic static discharge(ESD) protection)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
19(6.4) Are&nbsp;<A href="environmental.htm">environmental</A> <FONT 
color=#ff0000>concerns</FONT> taken into <FONT 
color=#ff0000>consideration</FONT>   
    
?<BR>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Does 
the <FONT color=#ff0000>supplire</FONT> use <FONT 
color=#ff0000>ecologically</FONT> friendly packaging materials? Are shipping 
<FONT color=#ff0000>regulations</FONT> <FONT color=#ff0000>obsered</FONT> as 
<FONT color=#ff0000>applicable</FONT> 
         
   
?<BR>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Are 
<FONT color=#ff0000>legal </FONT><FONT color=#ff0000>requirements</FONT> 
kept?(WEEE, ROHS, company guideline for <FONT color=#ff0000>dangerous</FONT> 
materials, environment <FONT color=#ff0000>protection</FONT> laws, ISO14001, if 
<FONT color=#ff0000>applicable</FONT> 
         
     )</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
20(6.3,6.4) Where failure to do so could adversely affect the product, do systems 
for preventive maintenance and servicing exist?(Measuring devices, test 
equipment, special fixtures, building, machines, assembly devices, production 
tools)</FONT></P>
<P><FONT size=4 
face=Arial>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
21(5.2) If processes or equipment have <FONT color=#ff0000>malfunctioned</FONT> 
or gone out of <FONT color=#ff0000>tolerance</FONT>: Is the effect on the 
product <FONT color=#ff0000>evaluated</FONT> to <FONT 
color=#ff0000>determine</FONT> its <FONT color=#ff0000>risk</FONT> ? If there is a <FONT color=#ff0000>hazard</FONT> 
to the user, is the customer <FONT color=#ff0000>informed</FONT>   
            
               
     ?</FONT></P><FONT size=4 
face=Arial>
<P><BR>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
22(7.4) Are(Sub) Suppliers cosen on the basis of quality and procurement 
requirements with enough time prior to start of productiong?</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
23(7.4) Do(Sub) suppliers become informed about defined customer expectations 
with regard to product quality and process quaity?(e.g., incoming inspection to 
deliveries, auality reports, 8D, statistics about supplier, supplier's manuals, 
realization of supplier audits, action plans with suppliers)</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24(7.4) 
Do the procurement data describe the product to be supplied appropriately? 
(Drawings, specifications) Are the(Sub) suppliers committed to do checks on 
their products/materials and how is this reflected in the procurement data 
again?(teting requirements, control level, key characteristics, reporting, 
documentation)</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
25(7.5 8.2.4 8.5.2 8.5.3) Is(sub) supplier performance reviewed and ensured that 
products and processes fulfill customers expectations and requirements? Is it 
ensured that root cause analysis and definition of appropriate corrective 
actions would be done if problems occur?(e.g. ppm-level,supplier evaluation, 
delivery performance)</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
26(7.3.7 8.2. 5.2) Are changes on the delivered product/material from(sub) 
suppliers verified and validated before implementation? Are changes communicated 
to the customer with possible consequences on the final product?</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
27(7.1 7.3.1 5.4) Are the requirements for the product planned?(Risks out of 
FMEA, ISO 14971 or similar requirements, specifications, verification, 
instructions, drawings, technical files,(customer) releases, final test or 
inspection criteria to ensure safety and effectiveness)</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
28(7.2.2) Are records/documentaiton kept during new product development as 
required?(contract review, document adaptation by changes in the process of 
development, change history, design history/technical file).</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;29(7.2.3) 
Do regulations, procedures exist to the communication with the customer? (offer, 
contract, order, changes, quality concerns, product information, frequency of 
communication)</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;30(7.3.1 
7.3.5 7.3.6) Are new product/process verification and validation activities 
aplanned prior to performance and prior to implementation fo the changes in the 
distributed product?(Project plans, milestones, net plans) Do the planned 
activities measure meaningful performance and safety criteria? are validations 
done using production made products of processes using actual planned tooling? 
do the validation runs represent start-up lot sizes anticipated?</P>
<P>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
31(7.3.2 7.5.5) Are new product inputs determined? Completely and not in 
contradiction?(results from FMeA analysis, lawful requirements, specifications, 
control plans, verification, instructions, drawings, potential users input, 
(customers) releases, not the given customer requirements but which are 
necessary for the deliberate use, after sales requirements). Are packaging and 
labeling requirements carefully considered to allow for distance shipping 
conditions and user needs?</P>
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